Artix AX

K223436 · Inari Medical · QEW · Mar 2, 2023 · Cardiovascular

Device Facts

• Record ID: K223436
• Device Name: Artix AX
• Applicant: Inari Medical
• Product Code: QEW · Cardiovascular
• Decision Date: Mar 2, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Artix AX aspiration catheter is indicated for: The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The Artix AX aspiration catheter is intended for use in the peripheral vasculature.

Device Story

Artix AX is a single-use, over-the-wire aspiration catheter for minimally invasive peripheral thrombectomy. Physician advances catheter over pre-placed guidewire to thrombus site. Artix MT may be deployed through Artix AX to engage thrombus; thrombus is then removed via aspiration using a 30 mL Large Bore Vacuum Syringe. Device facilitates clot removal, potentially improving blood flow in peripheral vessels. Used in clinical settings by physicians. Output is physical removal of thrombus/emboli. Benefits include minimally invasive clot management.

Clinical Evidence

Bench testing only. No clinical or animal data required. Verification/validation included biocompatibility (ISO 10993-1), sterilization (ISO 11135, AAMI TIR 28), and mechanical performance (kink radius, vacuum/leakage testing, clot burden removal, tensile/torque testing). All acceptance criteria met.

Technological Characteristics

Materials: Pebax (35D, 45D, 55D, 63D, 72D) with ProPell, etched PTFE, stainless steel coil. Dimensions: 2.8 mm OD / 2.4 mm ID; 85 cm/115 cm lengths. 30-degree tip bevel. Sterilization: EtO (SAL 10^-6). Guidewire compatibility: up to 0.035".

Indications for Use

Indicated for non-surgical removal of emboli/thrombi from blood vessels and injection/infusion/aspiration of contrast media/fluids in peripheral vasculature. Contraindicated for use in cerebral, carotid, coronary, and pulmonary arteries.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Inari FlowTriever Retrieval/Aspiration System (K213402)

Reference Devices

• Penumbra Indigo System CAT RX Aspiration Catheter (K163618)

Submission Summary (Full Text)

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March 2, 2023

Inari Medical Ellen Nguyen Regulatory Affairs Specialist 6001 Oak Canyon, Suite 100 Irvine. California 92618

Re: K223436

Trade/Device Name: Artix AX Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: OEW. KRA Dated: January 30, 2023 Received: January 31, 2023

Dear Ellen Nguyen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Gregory W. Digitally signed by
Gregory W. Gregory W. O'connell -S O'connell -S Pate: 2023.03.02
O'connell -S 16:27:18 -05'00'

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

Device Name Artix AX

| Indications for Use ( <i>Describe</i> ) |
|-----------------------------------------|
|-----------------------------------------|

The Artix AX aspiration catheter is indicated for:

- · The non-surgical removal of emboli and thrombi from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.

The Artix AX aspiration catheter is intended for use in the peripheral vasculature.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="15" y1="0" y2="15"></line> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="15" y1="15" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <svg height="15" width="15"> <rect height="15" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="15"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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K223436

PAGE 1 OF 5

# 510(K) SUMMARY

| Date prepared | March 1, 2023 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Inari Medical, Inc.<br>6001 Oak Canyon, Suite 100<br>Irvine, CA 92618<br>877.923.4747 |
| Contact person | Ellen Nguyen<br>Regulatory Affairs Specialist |
| Name of Device | Artix AX |
| Common name | Embolectomy catheter |
| Regulation name | Embolectomy catheter |
| Classification number | 21 CFR 870.5150 |
| Product code | QEW |
| Secondary product code | KRA |
| Regulatory class | II |
| Predicate device | Inari FlowTriever Retrieval/Aspiration System (K213402) |
| References devices | Penumbra Indigo System CAT RX Aspiration Catheter (K163618) |
| Description | The Artix AX is a single-use, over-the-wire catheter used for the minimally invasive<br>treatment of thromboemboli in the peripheral vasculature. The system comprises<br>two catheter lengths, 85 cm and 115 cm, packaged separately.<br><br>The Artix AX is inserted over a pre-placed guidewire and advanced to the<br>thrombus, which can then be removed via aspiration with the provided 30 mL<br>Large Bore Vacuum Syringe. The Artix MT may also be deployed through the<br>Artix AX to engage thrombus before being retracted through the Artix AX.<br>Additional clot may be removed by aspiration through the Artix AX as necessary.<br>After the procedure is complete, the Artix AX is removed from the patient. |
| Indications for Use | The Artix AX aspiration catheter is indicated for:<br>The non-surgical removal of emboli and thrombi from blood vessels. Injection, infusion, and/or aspiration of contrast media and other fluids into<br>or from a blood vessel.<br>The Artix AX aspiration catheter is intended for use in the peripheral vasculature. |
| Device Modifications | The proposed modifications are to the Triever16 component and include<br>dimensional and material changes to the catheter and removal of the dilator.<br><br>These modifications introduce the Artix AX, a smaller embolectomy catheter used<br>for aspiration thrombectomy in the peripheral vasculature.<br><br>There have been no changes to the Triever20 Fr/20 Curve and the Triever24 Fr<br>Catheters or the FlowTriever Catheters. |

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Comparison of Technological Characteristics with the Predicate Device

The proposed modifications do not change the intended use or principles of operation from the predicate device. The modified and predicate device have a similar design and mainly differ in dimensions and materials.

The Artix AX and Triever16 are both tracked over a pre-placed compatible guidewire. The Artix MT or FlowTriever Catheter can then be deployed through the Artix AX or Triever 16/20/24 Fr catheters respectively to engage and withdraw thrombus. Additional clot can be aspirated through the Artix AX or Triever16 using the provided 30 ml or 60 mL Large Bore Syringe.

Although the predicate and subject devices have different technological characteristics, all leveraged and performed design verification and validation tests confirm that these differences do not raise any new or different questions of safety or effectiveness.

There have been no changes to the Triever20 Fr/20 Curve or the Triever24 Fr Catheters or the FlowTriever Catheters.

Summary of substantial There is no change of intended use or fundamental scientific technology between the equivalence proposed device and predicate device. The Artix AX's indications for use falls within those of the predicate device. K213402: both are indicated for the non-surgical removal of emboli and thrombi from blood vessels and the injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. Both are intended for use in the peripheral vasculature. The Triever16 is additionally intended for the treatment of pulmonary embolism and for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

> A tabular comparison of specific technological characteristics between the predicate and subject device is provided below:

| Feature | Artix AX<br>Subject (TBD) | Triever16<br>Predicate (K213402) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Inari Medical | Inari Medical |
| Product code | QEW | QEW |
| Intended<br>use/Indications for<br>use | The Artix AX aspiration<br>catheter is indicated for:<br>The non-surgical removal<br>of emboli and thrombi<br>from blood vessels. Injection, infusion, and/or<br>aspiration of contrast<br>media and other fluids<br>into or from a blood<br>vessel. The Artix AX aspiration<br>catheter is intended for use in<br>the peripheral vasculature. | The Triever16 is indicated for:<br>The non-surgical removal<br>of emboli and thrombi<br>from blood vessels. Injection, infusion, and/or<br>aspiration of contrast<br>media and other fluids<br>into or from a blood<br>vessel. The Triever16 is intended for<br>use in the peripheral<br>vasculature and for the<br>treatment of pulmonary<br>embolism.<br>Triever Catheters are also |
| Feature | Artix MT<br>Subject (TBD) | Triever16<br>Predicate (K213402) |
| | | intended for use in treating clot<br>in transit in the right atrium but<br>not in conjunction with<br>FlowTriever Catheters. |
| Principles of<br>operation | The Artix AX is inserted over a<br>pre-placed guidewire and<br>advanced to the thrombus. The<br>Artix MT can then be deployed<br>through the Artix AX to engage<br>thrombus before being<br>retracted through the Artix AX.<br>Additional clot may be<br>removed by aspiration through<br>the Artix AX with the provided<br>30 mL Large Bore Vacuum<br>syringe. After the procedure is<br>complete, the Artix AX is<br>removed from the patient. | The Triever16 is inserted over<br>a pre-placed guidewire and<br>advanced to the thrombus. The<br>FlowTriever Catheter can then<br>be deployed through the<br>Triever16 to engage thrombus<br>before being retracted through<br>the Triever16. Additional clot<br>may be removed by aspiration<br>through the Triever16 with the<br>provided 60 mL Large Bore<br>Vacuum syringe. After the<br>procedure is complete, the<br>Triever 16 is removed from the<br>patient. |
| Target vessel | Peripheral vessels ≥ 3 mm | Peripheral vessels ≥ 6 mm,<br>pulmonary arteries, right heart |
| Contraindicated<br>vessels | Cerebral, carotid, coronary,<br>pulmonary arteries | Cerebral, carotid, coronary<br>arteries |
| Guidewire<br>compatibility | Up to 0.035" | Up to 0.035" |
| Shelf-life | 6 months | 2 years |
| Sterilization | EtO | EtO |
| Single-use | Yes | Yes |
| Dimensions | OD/ID: 2.8 mm/2.4 mm<br>Working length: 85 cm, 115 cm | OD/ID: 5.3 mm/4.5 mm<br>Working length: 107 cm |
| Outer Shaft<br>material | Pebax 35D with ProPell, Pebax<br>45D with ProPell, Pebax 55D<br>with ProPell, Pebax 63D,<br>Pebax 72D | Pebax 35D, Pebax 63D |
| Inner Shaft<br>Material | Etched PTFE | Etched PTFE |
| Metal support | Stainless steel coil | Stainless steel coil and braid |
| Hemostasis valve | Mini Garrote valve | Garrote valve |
| Tip bevel | 30° | No bevel |

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PAGE 3 OF 5

### Biocomnatibility

The following biocompatibility tests were completed for the subject device:

- . Cytotoxicity
- . Sensitization
- . Intracutaneous Reactivity
- Acute Systemic Toxicity

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#### PAGE 4 OF 5

- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Complement Activation, o Thromboresistance, Platelet and Leukocyte Count, and Partial Thromboplastin Time)

The passing results demonstrate that the subject device and accessories meet biological safety requirements per ISO 10993-1.

### Sterilization

The subject device, including its accessories, is sterilized using EtO to achieve a sterility assurance level (SAL) of 106. The subject device has been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014/Amd 1:2018 (Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E. Single batch release) and AAMI TIR 28:2016 (Product adoption and process equivalence for ethylene oxide sterilization) without deviations.

### Non-Clinical Testing

In accordance with the Design Failure Modes and Effects Analysis, verification and validation testing were identified to support the substantial equivalence of the Artix AX. These tests included:

- Pouch Seal Visual Inspection and Dye Penetration ●
- Visual & Dimensional Inspection ●
- Guidewire Compatibility ●
- Cheater Sheath Compatibility ●
- Artix MT/BG Compatibility and Simulated Use ●
- Kink Radius ●
- Air Leakage During Aspiration
- Leakage Testing ●
- Vacuum Testing ●
- Liquid Leakage Under Pressure (300 kPa) Testing
- Determination of Flowrate Through Catheter ●
- Burst Testing
- Clot Burden Removal Validation ●
- Simulated Use, Track & Tensile Catheter ●
- Simulated Use, Track & Torque Catheter ●
- 30 mL Large Bore Syringe Leak Testing ●
- 30 mL Large Bore Syringe Vacuum Testing
- Simulated Use & Tensile 30 mL Large Bore Syringe .
- . Simulated Use & Torque - 30 mL Large Bore Syringe

Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications.

Neither animal testing nor clinical testing were required for the determination of substantial equivalence.

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K223436

### Conclusion

The Artix AX has the same intended use/indications for use and principles of operation as the predicate. Performance data shows that the different technological characteristics between the devices do not raise any new or different questions of safety or effectiveness. Non-clinical bench testing supports the Artix AX's substantial equivalence to the predicate device.